What would you do if you received a warning letter from the FDA claiming your package label violated the Federal Food, Drug, and Cosmetic Act and giving you only 15 working days to identify the steps you will take to correct the issue?

This exact situation actually happens regularly to food manufacturers as the FDA monitors the marketplace for food labeling violations via consumer complaints and informal market surveys. FDA places particular emphasis on claims and statements made on the principal display panel (often referred to as front-of-package labeling) because they are used to catch shoppers’ attention, but often do not provide a full picture of the nutritional composition of the product.

Thankfully you don’t have to receive a warning letter directly to be able to learn some valuable lessons. These are four of the most common front-of-package violations found in food industry warning letters.

1. No disclosure statement next to a nutrient content claim.Consumers want the whole truth, and nothing but the truth! Package labels that make nutrient content claims about one nutrient, such as “0g trans fat”, but fail to identify high levels of “negative” nutrients that are present in the products, are in violation. Disclosure statements for high levels of total fat, saturated fat, cholesterol and/or sodium need to be included when making a nutrient content claim. Warning letters related to missing or incomplete disclosure statements have been sent to a variety of food manufacturers, including those who produce ice cream bars, fish fillets, pies, and vegetable shortening.

2. Invalid nutrient content claims.It would be nice if we could make product claims for how we want our product to benefit consumers or for what we feel like our products can do, but exaggeration just doesn’t cut it in the food labeling business. Nutrient content claims such as “cholesterol free”, and “excellent source of____” must meet the legal requirements approved and established by the FDA. Warning letters have been sent to manufacturers that produce vegetable shortening, fruit juice, and cereal products for making nutrient content claims that are inaccurate.

4 Lessons Learned from These Package Label Violations

3. Product claims not allowed on products intended for young children.There are a large number of products intended for infants and children less than two years of age that have been found to have unauthorized claims on their labels. These claims range from “healthy”, “no added sugar”, “good source of iron”, “low sodium”, “plus fiber”, etc.

Although the safety of these food products is not a concern, FDA has not authorized most nutrient content claims for foods that are intended for infants and toddlers. Warning letters have been sent to manufacturers that produce oatmeal, cereal puffs, fruit juice, and vegetable puree to correct or remove the claims.

4. Unauthorized health claims.Everyone would love to have a magic food that cured all their ailments, but in reality, health claims on food products are very limited and regulated. Invalid health claims do more than mislead consumers, they tarnish your brand.

Health claims for treating, preventing, or curing diseases, such as Alzheimer’s and cancer are not allowed on food products. These are considered to be drug claims. There are health claims that are allowed on package labels, such as the relationship between fiber-containing grain products, fruits, and vegetables and the reduced risk of coronary heart disease, but certain product specifications must be met before the claim is authorized. Warning letters have been sent to manufacturers that produce green tea, dried fruit, fruit juice, salad dressing, olive oil, and nuts to warn them that their package labels contain unauthorized health claims.

The bottom line is, make sure the statements made on your package labels are truthful, meaningful, and useful in helping consumers make proper food choices and construct healthy diets.

Labeling of FDA Regulated Food Products

April 21-22 Chicago, IL

Display labeling elements on your food packages that meet every detail of the latest FDA labeling requirements.

After this seminar you’ll know: • What regulatory changes impact your packages• How to avoid common labeling mistakes • What labeling elements are needed on your

package and where to properly place them

Practice labeling techniques with hands-on help from AIB’s knowledgeable, experienced professionals.

Labeling regulations are always changing. Don’t get left behind!

Enroll today! tiny.cc/aiblabeling